Munich – Formycon AG, a leading independent developer of biosimilar drugs, has received a scientific advice letter from the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development program for FYB201, the first biosimilar product candidate to emerge from its development pipeline, following the receipt of similarly favorable scientific advice from the European Medicines Agency (EMA) in December 2014. In its letter, the FDA, like the EMA, expresses its support for the company’s proposed approach to proceed with FYB201 directly to the pivotal phase III clinical trial. Based upon the scientific advices received from the EMA and FDA, Formycon and its license partner Bioeq GmbH are now in a position to carry forward with a clinical study design for a global phase III trial which will enable them to apply simultaneously for regulatory approval in both the U.S. and European Union. All preclinical activities and the preparations for the phase III trial for FYB201 are moving forward according to plan.
The market launch of FYB201 in the highly regulated markets, particularly the U.S. and European Union, is planned to begin starting from 2020.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.